Institute for Health Research IdiPAZ
Madrid, 28046, Spain
NCT Number: NCT05343858
The purpose of this study is to evaluate the effect of the consumption of two microalgae Chlorella vulgaris and Arthrospira platensis (Spirulina) on some biomarkers of metabolic syndrome: Total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, Apolipoprotein A and Apolipoprotein B, in overweight / obese subjects with altered lipid profile.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Madrid, 28046, Spain
A randomized, parallel, and double-blind pilot study with 3 study arms is being performed to evaluate the effect of the consumption of two unicellular microalgae: Chlorella vulgaris and Arthrospira platensis (Spirulina).
The investigators included 30 participants between 18 and 65 years (BMI ≥25 and <40 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products during 30 days.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
16 g/day (two doses of 8g)
16 g/day (two doses of 8g)
16 g/day (two doses of 8g)
Time frame: Change from baseline at 30 days
Biomarker of metabolic syndrome
Time frame: Change from baseline at 30 days
Biomarker of lipid profile quality
Time frame: Change from baseline at 30 days
Biomarker of lipid profile quality
Time frame: Change from baseline at 30 days
Biomarker of lipid profile quality
Time frame: Change from baseline at 30 days
Metabolic syndrome biomarker
Time frame: Change from baseline at 30 days
Metabolic syndrome biomarker
Time frame: Change from baseline at 30 days
Concentration of blood
Time frame: Change from baseline at 30 days
Changes on anthropometric characteristics
Time frame: Change from baseline at 30 days
Occurrence and frequency of gastrointestinal symptoms
Time frame: Change from baseline at 30 days
Changes on anthropometric characteristics
Time frame: Change from baseline at 30 days
Changes on anthropometric characteristics
Time frame: Change from baseline at 30 days
Changes in the number of consumed pills
Time frame: Change from baseline at 30 days
Visual Analog Scales (VAS) with a range between 0 (negative score) and 10 (positive score) related to taste, smell, texture, satiety and fullness
Time frame: Change from baseline at 30 days
Changes in diet composition through 24-hour dietary record
Time frame: Change from baseline at 30 days
Concentration of glucose
Time frame: Change from baseline at 30 days
Concentration of safety marker
Time frame: Change from baseline at 30 days
Concentration of creatinine
Time frame: Change from baseline at 30 days
Concentration of minerals
Instituto de Investigación Hospital Universitario La Paz
Other
Pilot Study to Evaluate the Effect of the Consumption of Two Unicellular Microalgae (Chlorella Vulgaris and Arthrospira Platensis (Spirulina)) on Metabolic Syndrome Biomarkers in Overweight / Obese Subjects With Altered Lipid Profile
Acronym: ALGAENERGY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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